Clinical trial · Observational
Patent Blue SLN in Early Ovarian Cancer Prospective Study (FIGO I-II) Evaluating Patent Blue SLN Mapping. Injection Into IP/UO Ligaments in Situ. Goals: Assess Feasibility and Accuracy vs Standard Lymphadenectomy to Minimize Surgical Morbidity
Evaluation of Sentinel Lymph Node Biopsy Using Patent Blue Dye in Early-Stage Ovarian Cancer: A Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
the standard of care in case of early ovarian cancer (stage I or II) is a complete surgery. This surgery includes : hysterectomy (remove of the uterus), bilateral salpingo-oophorectomy (remove of the adnexa), omentectomy (remove of the epiploon), bilateral pelvic lymphadenectomy (remove of pelvic lymph nodes) and para-aortic lymphadenectomy (remove of para-aortic lymph nodes). This procedure is diagnostic, curative and prognostic surgery. In fact, it allows us provider care giver to stratify the stage of the cancer, hence we give the appropriate adjuvant therapy. However, this surgery, especially the extended lymphadenectomy, is associated with some risks: lymphocele, vessel injury, blood loss, morbidity, long recovery period ... In order to reduce these risks, we propose a sentinel lymph node biopsy. This intervention allows us to detect first lymph node relay whether pelvic or para-aortic. In our study, we chose the patent blue dye as a tracer. This tracer is widely used in oncologic surgery (for example in breast cancer) and approved but not in ovarian cancer yet. During surgery for early stage ovarian cancer, we will inject the patent blue dye on both side of the ovarian tumor. Then, we will check for first colorful lymph node, in both pelvic and para-aortic regions. We will send these dissected lymph node to pathology for analysis. Finally, we will continue the procedure as the standard of care. Our objective is to compare the results between the sentinel lymph node and the complete lymphadenectomy and to study the technique of sentinel lymph node biopsy using the blue patent dye as tracer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage Ovarian Tumors | — | UNRESOLVED | — |
| Sentinel Lymph Node Biopsy (SLNB) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel node biopsy with patent blue dye | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with preoperative diagnosis of early stage ovarian cancer (FIGO stage I & II )
- description
- Patients with preoperative diagnosis (Using abdominal MRI and thoraco-abdomino-pelvic scan) of early stage ovarian cancer (FIGO stage I \& II ). Paitients with O-RADs 4 or 5 MRI ovarian tumors with or without elevated ovarian tumor markers.
- interventionNames
- Procedure: Sentinel node biopsy with patent blue dye
Primary outcomes (1)
- measure
- Technical feasibility
- timeFrame
- From the procedure to the pathology results at 4 weeks
- description
- Overall SLN Detection Rate: This is defined as the proportion of patients in whom at least one SLN is identified (either pelvic or para-aortic) using the blue tracer
Secondary outcomes (3)
- measure
- Negative predictive value
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age : aged 18 years-old or older * Diagnosis: Suspected Ovarian cancer on MRI finding (O-RADs 4 or 5) * FIGO stage: Stage I or II ( Based on MRI and scanner finding) * Planned Procedure: Patients with planned for surgical complete stadification including pelvic and para-aortic lymphadenectomy * Consent: Signing of the written informed consent after full information has been provided Exclusion Criteria: * Suspicious nodal involvement: Presence of suspicious lymph nodes on preoperative imaging (generally defined by a short-axis diameter ≥ 10 mm). * Disease extension: Radiological or intraoperative evidence of extra-pelvic metastases or peritoneal carcinomatosis. * Surgical history: History of lymphadenectomy, lymph node sampling, or major vascular surgery involving the aorta or the iliac vessels. * History of radiotherapy: Patients who have previously undergone pelvic or abdominal radiotherapy. * Allergies: Known allergy or adverse reaction to patent blue dyes.
References
Publications (19)
- BACKGROUNDKampan NC, Teik CK, Shafiee MN. Where are we going with sentinel nodes mapping in ovarian cancer? Front Oncol. 2022 Nov 3;12:999749. doi: 10.3389/fonc.2022.999749. eCollection 2022. PMID 36408149
- BACKGROUNDChen J, Yin J, Li Y, Gu Y, Wang W, Shan Y, Wang YX, Qin M, Cai Y, Jin Y, Pan L. Systematic Lymph Node Dissection May Be Abolished in Patients With Apparent Early-Stage Low-Grade Mucinous and Endometrioid Epithelial Ovarian Cancer. Front Oncol. 2021 Sep 6;11:705720. doi: 10.3389/fonc.2021.705720. eCollection 2021. PMID 34552868
- BACKGROUNDWang H, Wang S, Wang P, Han Y. Survival outcomes of lymph node dissection in early-stage epithelial ovarian cancer: identifying suitable candidates. World J Surg Oncol. 2024 Nov 7;22(1):294. doi: 10.1186/s12957-024-03571-7. PMID 39511679
- BACKGROUNDNero C, Bizzarri N, Di Berardino S, Sillano F, Vizzielli G, Cosentino F, Vargiu V, De Iaco P, Perrone AM, Vizza E, Chiofalo B, Uccella S, Ghezzi F, Turco LC, Corrado G, Giannarelli D, Pasciuto T, Zannoni GF, Fagotti A, Scambia G. Sentinel-node biopsy in apparent early stage ovarian cancer: final results of a prospective multicentre study (SELLY). Eur J Cancer. 2024 Jan;196:113435. doi: 10.1016/j.ejca.2023.113435. Epub 2023 Nov 14. PMID 38006759
- BACKGROUNDAtaei Nakhaei S, Sadeghi R, Mostafavi SM, Treglia G, Hassanzadeh M, Esmaeilpour M, Taheri NS, Farazestanian M. Sentinel Node Mapping in Ovarian Tumors: A Study Using Lymphoscintigraphy and SPECT/CT. Contrast Media Mol Imaging. 2024 Feb 23;2024:5453692. doi: 10.1155/2024/5453692. eCollection 2024. PMID 38435483
- BACKGROUNDAgusti N, Paredes P, Vidal-Sicart S, Glickman A, Torne A, Diaz-Feijoo B. Sentinel lymph node mapping in early-stage ovarian cancer: surgical technique in 10 steps. Int J Gynecol Cancer. 2022 Aug 1;32(8):1082-1083. doi: 10.1136/ijgc-2022-003420. No abstract available. PMID 35470254